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How Merck KGaA's new R&D chief is shaping the pipeline

With 16 months under his belt as the new head of global R&D for Merck KGaA's biopharmaceuticals division, Luciano Rossetti has pruned the pipeline, accelerated the unit's cancer immunotherapy efforts and revived one late-stage program. Evidence of whether he's put the pipeline on solid footing could come as early as next half, when many of these programs start to read out.

Rossetti, formerly SVP of late stage development at Merck & Co. Inc., came on board in July 2014. He replaced interim head of R&D Belén Garijo, who resumed her position as president and CEO of Merck's biopharma division.

The unit was in the midst of a two-year-long restructuring and had pruned its pipeline to 17 programs and narrowed its focus to cancer and autoimmune diseases. However, Rossetti felt there was still more he could do to hone the pipeline.

"They were in the middle of a transformation, but the pipeline was still slanted towards low-probability, late-stage assets that were very high risk, and some had already shown disappointing results," Rossetti told BioCentury.

He has cut six programs that either had poor results or were unlikely to be differentiated in competitive markets.

The division has also advanced six programs that were in the pipeline when Rossetti arrived. These include the rapid acceleration and expansion of avelumab, a mAb against PD-L1, from Phase II to Phase III, and from three tumor types to 13 discrete tumor types (see "Merck KGaA's Pipeline Progress").

The unit plans to follow a similar path of acceleration and expansion for its Phase Ib Bruton's tyrosine kinase (Btk) inhibitor, which was moved from preclinical to clinical testing under Rossetti's watch. It also will use the safety data it has collected over the last four years to resubmit a European regulatory application of cladribine for multiple sclerosis (MS).

If the division hits its milestones it could have at least three new product launches

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